Hybrid Senior Software Quality Engineer – Design Assurance

at Stryker

• Job title: Senior Software Quality Engineer – Design Assurance
• Job type: Full Time
• Experience level: Senior
• Salary: $89,300 - $193,400 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Portage, United States

About the role

• Senior Software Quality Engineer supporting medical digital health projects with a focus on software quality and compliance in a hybrid role.

Responsibilities

• Designed and tested prototypes and components, applying engineering principles to meet sub-system requirements and support product development
• Conducted root-cause analysis and problem-solving, evaluating solutions against technical and regulatory criteria
• Translated design inputs into engineering specifications, contributing to component-level and system-level architecture and documentation
• Developed software components, estimated development resources, and led code reviews to ensure alignment with design standards and best practices
• Collaborated cross-functionally with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes
• Created and maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards
• Demonstrated strong understanding of clinical use cases, customer needs, and product requirements to inform design decisions
• Adapted quickly to new systems and processes, showing initiative, ownership, and the ability to prioritize tasks with minimal supervision

Requirements

• Bachelor’s degree in a science or engineering
• Minimum of 2+ years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), Software Engineering, Information Technology, Healthcare IT or Systems Engineering
• Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science (preferred)
• Experience working through software lifecycle processes (Agile SAFe/Waterfall)
• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation
• Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills
• Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions
• Knowledge from using Application Lifecycle Management /Traceability tools.

Benefits

• salary plus bonus eligible
• benefits